Trial Outcomes & Findings for Study of Efficacy and Safety of Novel Spartalizumab Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma (NCT NCT03484923)

NCT ID: NCT03484923

Last Updated: 2024-06-18

Results Overview

ORR defined as the percentage of patients with a best overall response of either confirmed complete response (CR) or partial response (PR) as per local review by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and assessed by computed tomography (CT)/ magnetic resonance imaging (MRI). CR:Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

196 participants

Primary outcome timeframe

Up to 49 months (randomized section) and 18 months (non-randomized section)

Results posted on

2024-06-18

Participant Flow

None of the arms were opened in the extension part.

The screening period began once written informed consent was provided and ended after 28 days (or after 35 days for subjects screened for Arm 1A) or when subject was randomized/enrolled, whichever came first. 1 participant randomized to Arm 3 discontinued before study treatment due to an AE.

Participant milestones

Participant milestones
Measure
Arm 1: LAG525 + PDR001 (Randomized Section)
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 2: INC280+PDR001 (Randomized Section)
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 3: ACZ885 + PDR001 (Randomized Section)
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 4: LEE011 + PDR001 (Randomized Section)
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Overall Study
STARTED
45
43
43
44
21
Overall Study
Treated
45
43
42
44
21
Overall Study
COMPLETED
0
0
0
0
0
Overall Study
NOT COMPLETED
45
43
43
44
21

Reasons for withdrawal

Reasons for withdrawal
Measure
Arm 1: LAG525 + PDR001 (Randomized Section)
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 2: INC280+PDR001 (Randomized Section)
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 3: ACZ885 + PDR001 (Randomized Section)
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 4: LEE011 + PDR001 (Randomized Section)
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Overall Study
Adverse Event
3
3
5
11
1
Overall Study
Death
2
2
3
0
1
Overall Study
Physician Decision
6
7
6
3
2
Overall Study
Progressive disease
33
28
26
30
16
Overall Study
Subject Decision
1
3
3
0
1

Baseline Characteristics

Study of Efficacy and Safety of Novel Spartalizumab Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Arm 1: LAG525 + PDR001 (Randomized Section)
n=45 Participants
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 2: INC280+PDR001 (Randomized Section)
n=43 Participants
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 3: ACZ885 + PDR001 (Randomized Section)
n=43 Participants
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 4: LEE011 + PDR001 (Randomized Section)
n=44 Participants
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
n=21 Participants
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Total
n=196 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
Age, Categorical
Between 18 and 65 years
29 Participants
n=5 Participants
29 Participants
n=7 Participants
28 Participants
n=5 Participants
28 Participants
n=4 Participants
8 Participants
n=21 Participants
122 Participants
n=10 Participants
Age, Categorical
>=65 years
16 Participants
n=5 Participants
14 Participants
n=7 Participants
15 Participants
n=5 Participants
16 Participants
n=4 Participants
13 Participants
n=21 Participants
74 Participants
n=10 Participants
Sex: Female, Male
Female
17 Participants
n=5 Participants
21 Participants
n=7 Participants
15 Participants
n=5 Participants
14 Participants
n=4 Participants
9 Participants
n=21 Participants
76 Participants
n=10 Participants
Sex: Female, Male
Male
28 Participants
n=5 Participants
22 Participants
n=7 Participants
28 Participants
n=5 Participants
30 Participants
n=4 Participants
12 Participants
n=21 Participants
120 Participants
n=10 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
2 Participants
n=10 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
Race (NIH/OMB)
White
45 Participants
n=5 Participants
42 Participants
n=7 Participants
38 Participants
n=5 Participants
42 Participants
n=4 Participants
20 Participants
n=21 Participants
187 Participants
n=10 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
1 Participants
n=7 Participants
4 Participants
n=5 Participants
2 Participants
n=4 Participants
0 Participants
n=21 Participants
7 Participants
n=10 Participants

PRIMARY outcome

Timeframe: Up to 49 months (randomized section) and 18 months (non-randomized section)

Population: Randomized section: All participants to whom study treatment was assigned by randomization. Non-randomized section: All participants who received at least one dose of study treatment

ORR defined as the percentage of patients with a best overall response of either confirmed complete response (CR) or partial response (PR) as per local review by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and assessed by computed tomography (CT)/ magnetic resonance imaging (MRI). CR:Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure
Arm 1: LAG525 + PDR001 (Randomized Section)
n=45 Participants
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 2: INC280+PDR001 (Randomized Section)
n=43 Participants
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 3: ACZ885 + PDR001 (Randomized Section)
n=43 Participants
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 4: LEE011 + PDR001 (Randomized Section)
n=44 Participants
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
n=21 Participants
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Overall Response Rate (ORR)
8.9 Percentage of participants
Interval 2.5 to 21.2
4.7 Percentage of participants
Interval 0.6 to 15.8
4.7 Percentage of participants
Interval 0.6 to 15.8
6.8 Percentage of participants
Interval 1.4 to 18.7
14.3 Percentage of participants
Interval 3.0 to 36.3

SECONDARY outcome

Timeframe: From first documented response to disease progression or death due to any cause, whichever occurs first, assessed up to 49 months (randomized part) and 18 months (non-randomized part)

Population: Randomized section: All participants to whom study treatment was assigned by randomization for whom best overall response was complete response or partial response. Non-randomized section: All participants who received at least one dose of study treatment for whom best overall response was complete response or partial response

DOR defined as the time from date of first documented CR or PR to date of first documented disease progression (as per local review by RECIST v1.1 and assessed by CT/MRI) or death due to any cause. Subjects continuing without progression or death due to underlying cancer were censored at the date of their last adequate tumor assessment. CR:Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure
Arm 1: LAG525 + PDR001 (Randomized Section)
n=4 Participants
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 2: INC280+PDR001 (Randomized Section)
n=2 Participants
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 3: ACZ885 + PDR001 (Randomized Section)
n=2 Participants
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 4: LEE011 + PDR001 (Randomized Section)
n=3 Participants
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
n=3 Participants
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Duration of Response (DOR)
476 Days
Interval 169.0 to 1373.0
941.5 Days
Interval 504.0 to 1379.0
617.5 Days
Interval 113.0 to 1122.0
217 Days
Interval 169.0 to 281.0
281 Days
Interval 169.0 to 449.0

SECONDARY outcome

Timeframe: From randomization (or start of treatment for non-randomized section) to death due to any cause, assessed up to 49 months (randomized section) and 24 months (non-randomized section)

Population: Randomized section: All participants to whom study treatment was assigned by randomization. Non-randomized section: All participants who received at least one dose of study treatment

OS was defined as the time from date of randomization (or date of first dose of study treatment in non-randomized part) to date of death due to any cause. The OS distribution was estimated using the Kaplan-Meier method, and the medians and 95% confidence intervals of the medians were presented.

Outcome measures

Outcome measures
Measure
Arm 1: LAG525 + PDR001 (Randomized Section)
n=45 Participants
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 2: INC280+PDR001 (Randomized Section)
n=43 Participants
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 3: ACZ885 + PDR001 (Randomized Section)
n=43 Participants
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 4: LEE011 + PDR001 (Randomized Section)
n=44 Participants
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
n=21 Participants
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Overall Survival (OS)
8.8 Months
Interval 6.3 to 21.4
12.1 Months
Interval 6.6 to 18.5
8.7 Months
Interval 5.7 to 17.9
10.1 Months
Interval 7.4 to 15.6
14.0 Months
Interval 8.4 to
NA: Not estimable due to the insufficient number of participants with events

SECONDARY outcome

Timeframe: From randomization (or start of treatment for non-randomized section) to disease progression or death due to any cause, whichever occurs first, assessed up to 49 months (randomized section) and 18 months (non-randomized section)

Population: Randomized section: All participants to whom study treatment was assigned by randomization. Non-randomized section: All participants who received at least one dose of study treatment

PFS was defined as the time between the date of randomization (or date of first dose of study treatment in non-randomized section) to the date of event defined as the first documented disease progression (as per local review by RECIST v1.1 and assessed by CT/MRI) or death due to any cause. If a subject had not had an event before leaving study or initiation of subsequent anticancer therapy, PFS was censored at the date of last adequate tumor assessment. The PFS distribution was estimated using the Kaplan-Meier method, medians and 95% confidence interval of the medians were presented.

Outcome measures

Outcome measures
Measure
Arm 1: LAG525 + PDR001 (Randomized Section)
n=45 Participants
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 2: INC280+PDR001 (Randomized Section)
n=43 Participants
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 3: ACZ885 + PDR001 (Randomized Section)
n=43 Participants
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 4: LEE011 + PDR001 (Randomized Section)
n=44 Participants
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
n=21 Participants
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Progression Free Survival (PFS)
2.7 Months
Interval 1.7 to 2.8
2.7 Months
Interval 2.4 to 2.8
2.7 Months
Interval 2.6 to 2.8
2.8 Months
Interval 2.7 to 4.4
2.8 Months
Interval 2.7 to 4.6

SECONDARY outcome

Timeframe: Up to 49 months (randomized section) and 18 months (non-randomized section)

Population: Randomized section: All participants to whom study treatment was assigned by randomization. Non-randomized section: All participants who received at least one dose of study treatment

DCR was defined as the percentage of participants with best overall response of CR, PR or stable disease (SD) (as per local review by RECIST v1.1 and assessed by CT/MRI). CR:Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.

Outcome measures

Outcome measures
Measure
Arm 1: LAG525 + PDR001 (Randomized Section)
n=45 Participants
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 2: INC280+PDR001 (Randomized Section)
n=43 Participants
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 3: ACZ885 + PDR001 (Randomized Section)
n=43 Participants
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 4: LEE011 + PDR001 (Randomized Section)
n=44 Participants
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
n=21 Participants
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Disease Control Rate (DCR)
15.6 Percentage of participants
Interval 6.5 to 29.5
16.3 Percentage of participants
Interval 6.8 to 30.7
18.6 Percentage of participants
Interval 8.4 to 33.4
31.8 Percentage of participants
Interval 18.6 to 47.6
33.3 Percentage of participants
Interval 14.6 to 57.0

SECONDARY outcome

Timeframe: At Baseline

Population: Randomized section: Participants to whom study treatment was assigned by randomization with a determinant baseline immunogenicity sample for PDR001. Non-randomized section: Participants who received at least one dose of treatment with a determinant baseline immunogenicity sample for PDR001.

Percentage of participants who had a PDR001 ADA positive result at baseline.

Outcome measures

Outcome measures
Measure
Arm 1: LAG525 + PDR001 (Randomized Section)
n=43 Participants
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 2: INC280+PDR001 (Randomized Section)
n=38 Participants
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 3: ACZ885 + PDR001 (Randomized Section)
n=40 Participants
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 4: LEE011 + PDR001 (Randomized Section)
n=41 Participants
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
n=20 Participants
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Percentage of Participants With PDR001 Anti-drug Antibodies (ADA) Positive Result at Baseline
1 Participants
0 Participants
1 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: At Baseline

Population: Randomized section: Participants randomized to Arm 1 with a determinant baseline immunogenicity sample for LAG525. Non-randomized section: Participants who received at least one dose of treatment with a determinant baseline immunogenicity sample for LAG525.

Percentage of participants who had a LAG525 ADA positive result at baseline. Only applicable for participants enrolled in Arm 1 and Arm 1A.

Outcome measures

Outcome measures
Measure
Arm 1: LAG525 + PDR001 (Randomized Section)
n=43 Participants
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 2: INC280+PDR001 (Randomized Section)
n=20 Participants
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 3: ACZ885 + PDR001 (Randomized Section)
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 4: LEE011 + PDR001 (Randomized Section)
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Percentage of Participants With LAG525 Anti-drug Antibodies (ADA) Positive Result at Baseline
3 Participants
0 Participants

SECONDARY outcome

Timeframe: At Baseline

Population: Participants randomized to Arm 3 with a determinant baseline immunogenicity sample for ACZ885.

Percentage of participants who had an ACZ885 ADA positive result at baseline. Only applicable for subjects enrolled in Arm 3.

Outcome measures

Outcome measures
Measure
Arm 1: LAG525 + PDR001 (Randomized Section)
n=39 Participants
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 2: INC280+PDR001 (Randomized Section)
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 3: ACZ885 + PDR001 (Randomized Section)
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 4: LEE011 + PDR001 (Randomized Section)
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Percentage of Participants With ACZ885 Anti-drug Antibodies (ADA) Positive Result at Baseline
0 Participants

SECONDARY outcome

Timeframe: Pre-infusion on Day 1 of Cycle 1, 2, 3, 4, 5, 6 and thereafter every 3 cycles until end of treatment (EOT), EOT, and 30 and 150 days post-EOT (assessed up to 49 months randomized section and 24 months non-randomized section). Cycle= 28 days

Population: Randomized section: Participants to whom study treatment was assigned by randomization with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample. Non-randomized section: Participants who received at least one dose of study treatment with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample.

Percentage of participants who tested positive for treatment-induced ADA for PDR001 (subjects with ADA-negative sample at baseline with at least one post-baseline ADA positive sample) as well as treatment-boosted ADA for PDR001 (subjects with baseline positive ADA titre that was boosted to a 4-fold or higher-level following treatment).

Outcome measures

Outcome measures
Measure
Arm 1: LAG525 + PDR001 (Randomized Section)
n=40 Participants
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 2: INC280+PDR001 (Randomized Section)
n=34 Participants
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 3: ACZ885 + PDR001 (Randomized Section)
n=38 Participants
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 4: LEE011 + PDR001 (Randomized Section)
n=39 Participants
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
n=19 Participants
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Percentage of Participants Who Were Treatment-induced ADA Positive and Treatment-boosted ADA Positive for PDR001
3 Participants
5 Participants
3 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Pre-infusion on Day 1 of Cycle 1, 2, 3, 4, 5, 6 and thereafter every 3 cycles until end of treatment (EOT) and EOT (assessed up to 49 months in the randomized section and 18 months in the non-randomized section). Cycle= 28 days

Population: Randomized section: Participants randomized to Arm 1 with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample. Non-randomized section: Participants who received at least one dose of study treatment with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample.

Percentage of participants who tested positive for treatment-induced ADA for LAG525 (subjects with ADA-negative sample at baseline with at least one post-baseline ADA positive sample) as well as treatment-boosted ADA for LAG525 (subjects with baseline positive ADA titre that was boosted to a 4-fold or higher-level following treatment). Only applicable for subjects enrolled in Arm 1 and Arm 1A.

Outcome measures

Outcome measures
Measure
Arm 1: LAG525 + PDR001 (Randomized Section)
n=40 Participants
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 2: INC280+PDR001 (Randomized Section)
n=19 Participants
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 3: ACZ885 + PDR001 (Randomized Section)
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 4: LEE011 + PDR001 (Randomized Section)
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Percentage of Participants Who Were Treatment-induced ADA Positive and Treatment-boosted ADA Positive for LAG525
7 Participants
2 Participants

SECONDARY outcome

Timeframe: Pre-infusion on Day 1 of Cycle 1, 2, 3, 4, 5, 6 and thereafter every 3 cycles until end of treatment (EOT) and EOT (assessed up to 40 months). Cycle= 28 days

Population: Participants randomized to Arm 3 with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample.

Percentage of participants who tested positive for treatment-induced ADA for ACZ885 (subjects with ADA-negative sample at baseline with at least one post-baseline ADA positive sample) as well as treatment-boosted ADA for ACZ885 (subjects with baseline positive ADA titre that was boosted to a 4-fold or higher-level following treatment). Only applicable for subjects enrolled in Arm 3.

Outcome measures

Outcome measures
Measure
Arm 1: LAG525 + PDR001 (Randomized Section)
n=38 Participants
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 2: INC280+PDR001 (Randomized Section)
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 3: ACZ885 + PDR001 (Randomized Section)
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 4: LEE011 + PDR001 (Randomized Section)
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Percentage of Participants Who Were Treatment-induced ADA Positive and Treatment-boosted ADA Positive for ACZ885
1 Participants

SECONDARY outcome

Timeframe: Baseline and after 3-4 weeks of treatment

Population: Participants who received at least one dose of treatment with an evaluable baseline tumor biopsy sample and at least one evaluable post-baseline tumor biopsy sample with evaluable results for the three biomarker parameters.

Biomarker parameters included: 1) number of tumor infiltrating T cells (TIL), 2) activation level of TIL, and 3) changes in immune response gene expression signatures. For the number of TILs, an increase in tumoral CD8+ cell numbers compared to baseline was considered favorable. The activation level of TIL was assessed by the percentage of tumoral CD8+ cells expressing GzmB (a marker for cytotoxic activity) or Ki67 (a marker for cell proliferation), where an increase in either GZMB+/CD8+ or KI67+/CD8+ post-baseline was considered favorable. Changes in immune response gene expression signatures were evaluated by the levels in T-cell inflamed signature (TIS), where an increase from baseline was considered favorable. To be categorized as having a pFBP, a subject must meet the favorable criteria for at least two of the three biomarker parameters. The percentage of participants with pFBP was assessed.

Outcome measures

Outcome measures
Measure
Arm 1: LAG525 + PDR001 (Randomized Section)
n=22 Participants
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 2: INC280+PDR001 (Randomized Section)
n=21 Participants
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 3: ACZ885 + PDR001 (Randomized Section)
n=31 Participants
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 4: LEE011 + PDR001 (Randomized Section)
n=6 Participants
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Percentage of Participants With a Favorable Biomarker Profile (pFBP)
13.6 Percentage of participants
Interval 2.9 to 34.9
4.8 Percentage of participants
Interval 0.1 to 23.8
6.5 Percentage of participants
Interval 0.8 to 21.4
16.7 Percentage of participants
Interval 0.4 to 64.1

POST_HOC outcome

Timeframe: Pre-treatment: up to 28/35 days (randomized/non-randomized). On-treatment: up to 49/19 months (randomized/non-randomized). Extended safety FU and Post-treatment survival FU: up to 49/24 months (randomized/non-randomized).

Population: Randomized section: All participants to whom study treatment was assigned by randomization. Non-randomized section: All participants who received at least one dose of study treatment

Pre-treatment: deaths collected from day of patient's informed consent to the day before the first administration of study treatment. On-treatment: deaths collected from start of treatment to 30 days after last dose of study treatment. Extended safety follow-up: deaths collected from 31 days after last dose of study treatment up to 150 days after last dose of PDR001 (if this timepoint was later than 30 days after last dose of study treatment) Post-treatment survival follow-up: deaths collected from day 151 post-last dose of PDR001 or 31 days after last dose of study treatment (whichever occurred last) up to end of study.

Outcome measures

Outcome measures
Measure
Arm 1: LAG525 + PDR001 (Randomized Section)
n=45 Participants
Participants randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 2: INC280+PDR001 (Randomized Section)
n=43 Participants
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 3: ACZ885 + PDR001 (Randomized Section)
n=43 Participants
Participants randomized to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 4: LEE011 + PDR001 (Randomized Section)
n=44 Participants
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Arm 1A: LAG525 + PDR001 (Non-randomized Section)
n=21 Participants
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
All Collected Deaths
All deaths
37 Participants
33 Participants
33 Participants
33 Participants
12 Participants
All Collected Deaths
Pre-treatment deaths
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
All Collected Deaths
On-treatment deaths
5 Participants
3 Participants
3 Participants
3 Participants
1 Participants
All Collected Deaths
Extended safety follow-up deaths
14 Participants
11 Participants
15 Participants
11 Participants
4 Participants
All Collected Deaths
Post-treatment survival follow-up deaths
18 Participants
19 Participants
15 Participants
19 Participants
7 Participants

Adverse Events

Arm 2: INC280+PDR001 (Randomized Part)- On-treatment Period

Serious events: 21 serious events
Other events: 42 other events
Deaths: 3 deaths

Arm 2: INC280+PDR001 (Randomized Part) - Extended Safety Follow-up

Serious events: 0 serious events
Other events: 6 other events
Deaths: 11 deaths

Arm 2: INC280+PDR001 (Randomized Part)- Post-treatment Survival Follow-up

Serious events: 0 serious events
Other events: 0 other events
Deaths: 19 deaths

Arm 3: ACZ885 + PDR001 (Randomized Part)- On-treatment Period

Serious events: 12 serious events
Other events: 32 other events
Deaths: 3 deaths

Arm 3: ACZ885 + PDR001 (Randomized Part)- Extended Safety Follow-up

Serious events: 4 serious events
Other events: 5 other events
Deaths: 15 deaths

Arm 3: ACZ885 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up

Serious events: 0 serious events
Other events: 0 other events
Deaths: 15 deaths

Arm 4: LEE011 + PDR001 (Randomized Part)- On-treatment Period

Serious events: 22 serious events
Other events: 44 other events
Deaths: 3 deaths

Arm 4: LEE011 + PDR001 (Randomized Part)- Extended Safety Follow-up

Serious events: 8 serious events
Other events: 9 other events
Deaths: 11 deaths

Arm 4: LEE011 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up

Serious events: 0 serious events
Other events: 0 other events
Deaths: 19 deaths

Arm 1A: LAG525 + PDR001 (Non-randomized Part)- On-treatment Period

Serious events: 7 serious events
Other events: 18 other events
Deaths: 1 deaths

Arm 1A: LAG525 + PDR001 (Non-randomized Part)- Extended Safety Follow-up

Serious events: 2 serious events
Other events: 2 other events
Deaths: 4 deaths

Arm 1A: LAG525 + PDR001 (Non-randomized Part)- Post-treatment Survival Follow-up

Serious events: 0 serious events
Other events: 0 other events
Deaths: 7 deaths

Arm 1: LAG525 + PDR001 (Randomized Part)- On-treatment Period

Serious events: 21 serious events
Other events: 40 other events
Deaths: 5 deaths

Arm 1: LAG525 + PDR001 (Randomized Part)- Extended Safety Follow-up

Serious events: 5 serious events
Other events: 5 other events
Deaths: 14 deaths

Arm 1: LAG525 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up

Serious events: 0 serious events
Other events: 0 other events
Deaths: 18 deaths

Serious adverse events

Serious adverse events
Measure
Arm 2: INC280+PDR001 (Randomized Part)- On-treatment Period
n=43 participants at risk
AEs collected during on-treatment period (up to 30 days post-treatment)
Arm 2: INC280+PDR001 (Randomized Part) - Extended Safety Follow-up
n=43 participants at risk
AEs collected during extended safety follow-up period (from day 31 post-treatment up to 150 days post last dose of PDR001 \[if \>30 days post-treatment\])
Arm 2: INC280+PDR001 (Randomized Part)- Post-treatment Survival Follow-up
Deaths collected in the post- treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period
Arm 3: ACZ885 + PDR001 (Randomized Part)- On-treatment Period
n=42 participants at risk
AEs collected during on-treatment period (up to 30 days post-treatment)
Arm 3: ACZ885 + PDR001 (Randomized Part)- Extended Safety Follow-up
n=42 participants at risk
AEs collected during extended safety follow-up period (from day 31 post-treatment up to 150 days post last dose of PDR001 \[if \>30 days post-treatment\])
Arm 3: ACZ885 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up
Deaths collected in the post- treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period
Arm 4: LEE011 + PDR001 (Randomized Part)- On-treatment Period
n=44 participants at risk
AEs collected during on-treatment period (up to 30 days post-treatment)
Arm 4: LEE011 + PDR001 (Randomized Part)- Extended Safety Follow-up
n=44 participants at risk
AEs collected during extended safety follow-up period (from day 31 post-treatment up to 150 days post last dose of PDR001 \[if \>30 days post-treatment\])
Arm 4: LEE011 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up
Deaths collected in the post- treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period
Arm 1A: LAG525 + PDR001 (Non-randomized Part)- On-treatment Period
n=21 participants at risk
AEs collected during on-treatment period (up to 30 days post-treatment)
Arm 1A: LAG525 + PDR001 (Non-randomized Part)- Extended Safety Follow-up
n=21 participants at risk
AEs collected during extended safety follow-up period (from day 31 post-treatment up to 150 days post last dose of PDR001 \[if \>30 days post-treatment\])
Arm 1A: LAG525 + PDR001 (Non-randomized Part)- Post-treatment Survival Follow-up
Deaths collected in the post- treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period
Arm 1: LAG525 + PDR001 (Randomized Part)- On-treatment Period
n=45 participants at risk
AEs collected during on-treatment period (up to 30 days post-treatment)
Arm 1: LAG525 + PDR001 (Randomized Part)- Extended Safety Follow-up
n=45 participants at risk
AEs collected during extended safety follow-up period (from day 31 post-treatment up to 150 days post last dose of PDR001 \[if \>30 days post-treatment\])
Arm 1: LAG525 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up
Deaths collected in the post- treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period
Blood and lymphatic system disorders
Anaemia
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Blood and lymphatic system disorders
Febrile neutropenia
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Cardiac disorders
Acute myocardial infarction
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Cardiac disorders
Atrial fibrillation
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Cardiac disorders
Myocarditis
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Endocrine disorders
Adrenal haematoma
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Endocrine disorders
Hypercalcaemia of malignancy
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Gastrointestinal disorders
Abdominal pain
4.7%
2/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Gastrointestinal disorders
Autoimmune colitis
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Gastrointestinal disorders
Diarrhoea
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Gastrointestinal disorders
Dysphagia
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Gastrointestinal disorders
Gastritis
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Gastrointestinal disorders
Immune-mediated enterocolitis
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Gastrointestinal disorders
Intestinal obstruction
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Gastrointestinal disorders
Intussusception
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Gastrointestinal disorders
Nausea
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.4%
2/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Gastrointestinal disorders
Small intestinal obstruction
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Gastrointestinal disorders
Subileus
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Gastrointestinal disorders
Vomiting
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
General disorders
Asthenia
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
General disorders
Chest pain
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
General disorders
Fatigue
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
General disorders
General physical health deterioration
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Hepatobiliary disorders
Hepatitis
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
General disorders
Heteroplasia
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
General disorders
Multiple organ dysfunction syndrome
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
General disorders
Oedema peripheral
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
General disorders
Pain
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
General disorders
Pyrexia
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Hepatobiliary disorders
Cholangitis
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Hepatobiliary disorders
Drug-induced liver injury
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Hepatobiliary disorders
Hepatic cytolysis
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Hepatobiliary disorders
Hepatitis acute
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Hepatobiliary disorders
Hypertransaminasaemia
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Hepatobiliary disorders
Immune-mediated hepatitis
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Immune system disorders
Cytokine release syndrome
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Immune system disorders
Drug hypersensitivity
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Infections and infestations
Cellulitis
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Infections and infestations
Erysipelas
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Infections and infestations
Infection
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Infections and infestations
Pneumonia
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.4%
2/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Infections and infestations
Pneumonia bacterial
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Infections and infestations
Respiratory tract infection
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Infections and infestations
Sepsis
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Infections and infestations
Skin infection
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Infections and infestations
Suspected COVID-19
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Injury, poisoning and procedural complications
Femur fracture
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Injury, poisoning and procedural complications
Humerus fracture
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Injury, poisoning and procedural complications
Ocular procedural complication
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Investigations
Blood lactic acid increased
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Investigations
General physical condition abnormal
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.4%
2/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Investigations
Haemoglobin decreased
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Investigations
Liver function test abnormal
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Investigations
Liver function test increased
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Metabolism and nutrition disorders
Cachexia
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Metabolism and nutrition disorders
Dehydration
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Metabolism and nutrition disorders
Diabetes mellitus
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Metabolism and nutrition disorders
Hypoalbuminaemia
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Musculoskeletal and connective tissue disorders
Arthralgia
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Musculoskeletal and connective tissue disorders
Myositis
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Musculoskeletal and connective tissue disorders
Pathological fracture
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
9.5%
2/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spleen
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncologic complication
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.4%
2/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
2/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Nervous system disorders
Cerebral haemorrhage
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Nervous system disorders
Diabetic hyperglycaemic coma
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Nervous system disorders
Dizziness
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Nervous system disorders
Epilepsy
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Nervous system disorders
Facial paresis
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Nervous system disorders
Haemorrhage intracranial
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Nervous system disorders
Headache
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Nervous system disorders
Hemiparesis
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Nervous system disorders
Hypoglossal nerve disorder
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Nervous system disorders
Nervous system disorder
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Nervous system disorders
Peripheral nerve paresis
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Nervous system disorders
Seizure
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Nervous system disorders
Spinal cord compression
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Product Issues
Device dislocation
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Renal and urinary disorders
Acute kidney injury
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Renal and urinary disorders
Renal failure
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Reproductive system and breast disorders
Pelvic pain
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Respiratory, thoracic and mediastinal disorders
Haemothorax
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Skin and subcutaneous tissue disorders
Rash
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Vascular disorders
Deep vein thrombosis
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Vascular disorders
Hypotension
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Vascular disorders
Peripheral ischaemia
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Vascular disorders
Phlebitis
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Vascular disorders
Vena cava thrombosis
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Vascular disorders
Venous thrombosis
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment

Other adverse events

Other adverse events
Measure
Arm 2: INC280+PDR001 (Randomized Part)- On-treatment Period
n=43 participants at risk
AEs collected during on-treatment period (up to 30 days post-treatment)
Arm 2: INC280+PDR001 (Randomized Part) - Extended Safety Follow-up
n=43 participants at risk
AEs collected during extended safety follow-up period (from day 31 post-treatment up to 150 days post last dose of PDR001 \[if \>30 days post-treatment\])
Arm 2: INC280+PDR001 (Randomized Part)- Post-treatment Survival Follow-up
Deaths collected in the post- treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period
Arm 3: ACZ885 + PDR001 (Randomized Part)- On-treatment Period
n=42 participants at risk
AEs collected during on-treatment period (up to 30 days post-treatment)
Arm 3: ACZ885 + PDR001 (Randomized Part)- Extended Safety Follow-up
n=42 participants at risk
AEs collected during extended safety follow-up period (from day 31 post-treatment up to 150 days post last dose of PDR001 \[if \>30 days post-treatment\])
Arm 3: ACZ885 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up
Deaths collected in the post- treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period
Arm 4: LEE011 + PDR001 (Randomized Part)- On-treatment Period
n=44 participants at risk
AEs collected during on-treatment period (up to 30 days post-treatment)
Arm 4: LEE011 + PDR001 (Randomized Part)- Extended Safety Follow-up
n=44 participants at risk
AEs collected during extended safety follow-up period (from day 31 post-treatment up to 150 days post last dose of PDR001 \[if \>30 days post-treatment\])
Arm 4: LEE011 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up
Deaths collected in the post- treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period
Arm 1A: LAG525 + PDR001 (Non-randomized Part)- On-treatment Period
n=21 participants at risk
AEs collected during on-treatment period (up to 30 days post-treatment)
Arm 1A: LAG525 + PDR001 (Non-randomized Part)- Extended Safety Follow-up
n=21 participants at risk
AEs collected during extended safety follow-up period (from day 31 post-treatment up to 150 days post last dose of PDR001 \[if \>30 days post-treatment\])
Arm 1A: LAG525 + PDR001 (Non-randomized Part)- Post-treatment Survival Follow-up
Deaths collected in the post- treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period
Arm 1: LAG525 + PDR001 (Randomized Part)- On-treatment Period
n=45 participants at risk
AEs collected during on-treatment period (up to 30 days post-treatment)
Arm 1: LAG525 + PDR001 (Randomized Part)- Extended Safety Follow-up
n=45 participants at risk
AEs collected during extended safety follow-up period (from day 31 post-treatment up to 150 days post last dose of PDR001 \[if \>30 days post-treatment\])
Arm 1: LAG525 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up
Deaths collected in the post- treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period
Blood and lymphatic system disorders
Anaemia
14.0%
6/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
14.3%
6/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
25.0%
11/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
14.3%
3/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
6.7%
3/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.4%
2/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Blood and lymphatic system disorders
Eosinophilia
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
7.1%
3/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Blood and lymphatic system disorders
Leukopenia
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
9.1%
4/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.4%
2/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Blood and lymphatic system disorders
Lymphopenia
4.7%
2/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
15.9%
7/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.4%
2/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Blood and lymphatic system disorders
Neutropenia
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
45.5%
20/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
6.7%
3/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Blood and lymphatic system disorders
Thrombocytopenia
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
6.8%
3/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Endocrine disorders
Hypothyroidism
4.7%
2/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
9.5%
2/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.4%
2/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Gastrointestinal disorders
Abdominal pain
7.0%
3/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
11.9%
5/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
11.4%
5/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
9.5%
2/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
11.1%
5/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Gastrointestinal disorders
Constipation
14.0%
6/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
16.7%
7/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
6.8%
3/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
17.8%
8/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Gastrointestinal disorders
Diarrhoea
23.3%
10/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
7.1%
3/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
20.5%
9/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
23.8%
5/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
13.3%
6/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Gastrointestinal disorders
Dry mouth
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
9.5%
4/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
6.7%
3/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Gastrointestinal disorders
Nausea
41.9%
18/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
21.4%
9/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
34.1%
15/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
28.6%
6/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
28.9%
13/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Gastrointestinal disorders
Vomiting
25.6%
11/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
7.1%
3/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
18.2%
8/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
14.3%
3/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
13.3%
6/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
General disorders
Asthenia
16.3%
7/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
16.7%
7/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
18.2%
8/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
33.3%
7/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
20.0%
9/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
General disorders
Chest pain
7.0%
3/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.4%
2/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
General disorders
Chills
7.0%
3/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
General disorders
Fatigue
11.6%
5/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
11.9%
5/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
18.2%
8/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
19.0%
4/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
15.6%
7/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
General disorders
Oedema peripheral
23.3%
10/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
6.8%
3/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
6.7%
3/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
General disorders
Pain
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
8.9%
4/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
General disorders
Pyrexia
30.2%
13/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
2/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
18.2%
8/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
9.5%
2/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
6.7%
3/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Hepatobiliary disorders
Hepatic cytolysis
4.7%
2/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
6.8%
3/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Infections and infestations
Rhinitis
7.0%
3/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
2/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
6.7%
3/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Investigations
Alanine aminotransferase increased
14.0%
6/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
2/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
34.1%
15/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Investigations
Amylase increased
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
7.1%
3/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
6.8%
3/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Investigations
Aspartate aminotransferase increased
11.6%
5/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
7.1%
3/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
38.6%
17/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Investigations
Blood alkaline phosphatase increased
4.7%
2/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
2/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
8.9%
4/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Investigations
Blood creatinine increased
11.6%
5/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
9.1%
4/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Investigations
Blood lactate dehydrogenase increased
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
6.7%
3/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.4%
2/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Investigations
Blood potassium decreased
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
9.5%
2/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Investigations
Electrocardiogram QT prolonged
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
6.8%
3/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Investigations
Gamma-glutamyltransferase increased
4.7%
2/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
6.8%
3/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.4%
2/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Investigations
Haemoglobin decreased
4.7%
2/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
9.5%
2/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Investigations
Lipase increased
7.0%
3/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
7.1%
3/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
11.4%
5/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
9.5%
2/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
6.7%
3/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Investigations
Neutrophil count decreased
4.7%
2/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
6.8%
3/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Investigations
Platelet count decreased
7.0%
3/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.4%
2/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Investigations
SARS-CoV-2 test negative
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
9.1%
4/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Investigations
Weight decreased
4.7%
2/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
11.9%
5/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
9.1%
4/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
13.3%
6/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Investigations
White blood cell count decreased
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
9.1%
4/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Metabolism and nutrition disorders
Decreased appetite
7.0%
3/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
16.7%
7/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
20.5%
9/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
9.5%
2/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
22.2%
10/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Metabolism and nutrition disorders
Hypoalbuminaemia
7.0%
3/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Musculoskeletal and connective tissue disorders
Arthralgia
4.7%
2/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
2/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
11.1%
5/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Musculoskeletal and connective tissue disorders
Back pain
9.3%
4/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
2/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
13.6%
6/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
9.5%
2/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
11.1%
5/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Musculoskeletal and connective tissue disorders
Pain in extremity
7.0%
3/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.7%
2/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
6.8%
3/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
11.1%
5/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
9.5%
2/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
6.8%
3/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.4%
2/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Nervous system disorders
Dizziness
4.7%
2/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
6.8%
3/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
6.7%
3/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Nervous system disorders
Headache
11.6%
5/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
2/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
9.1%
4/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
9.5%
2/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
6.7%
3/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Nervous system disorders
Paraesthesia
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
6.8%
3/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
9.5%
2/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Psychiatric disorders
Insomnia
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.4%
1/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
9.1%
4/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
1/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.4%
2/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Respiratory, thoracic and mediastinal disorders
Cough
18.6%
8/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
2/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
18.2%
8/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
6.7%
3/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Respiratory, thoracic and mediastinal disorders
Dyspnoea
14.0%
6/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
19.0%
8/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
9.1%
4/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Skin and subcutaneous tissue disorders
Eczema
2.3%
1/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
6.8%
3/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Skin and subcutaneous tissue disorders
Pruritus
14.0%
6/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
7.1%
3/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
18.2%
8/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
14.3%
3/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
24.4%
11/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Skin and subcutaneous tissue disorders
Rash
18.6%
8/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
7.1%
3/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
9.1%
4/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.3%
1/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
8.9%
4/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Skin and subcutaneous tissue disorders
Vitiligo
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.8%
2/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
4.5%
2/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
9.5%
2/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
8.9%
4/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
Vascular disorders
Hypertension
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/43 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/42 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
6.8%
3/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/44 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/21 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
2.2%
1/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0.00%
0/45 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment
0/0 • On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered AEs. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period. Safety analyses were performed in the safety set, including all participants who received at least one dose of treatment

Additional Information

Study director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

  • Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
  • Publication restrictions are in place

Restriction type: OTHER